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FDA accepts first digital medicine new drug application

The combination product treats serious mental illness, includes an ingestible sensor in a single tablet, and is supposed to help with patient adherence.

The FDA has decided that the New Drug Application for the combination product of ABILIFY embedded with a Proteus ingestible sensor in a single tablet is sufficiently complete to allow for a substantive review.

This is the first time an FDA-approved medication (has been combined and submitted for approval with a sensor within the medication tablet to measure actual medication-taking patterns and physiologic response, according to Proteus Digital Health, the makers of the sensor.

The sensor is expected to help with patient adherence, because the ABILIFY tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring adherence.

“Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression,” said William H. Carson, M.D., President and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc., the makers of ABILFY. “We believe this new digital medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population.”

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